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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
| SLK Kliniken Heilbronn GmbH | OTHER |
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The Aim is to evaluate safety and efficacy of TACE with doxorubicin-loaded DC beads in melanoma patients with liver metastasis. This is a pilot study with the aim of recruiting 20 patients, this is a feasibility study. the patients profile is patients with stage IV Melanoma with liver metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage IV melanoma patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE using Drug Eluting Beads loaded with Doxorubicin | Device | 100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients completing scheduled treatment plan | Safety: Adverse Events Efficacy: Response to Treatment | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant or breast feeding.
Patients eligible for curative treatment such as resection or radiofrequency ablation.
Active bacterial, viral or fungal infection within 72 hours of study entry.
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated < 5 years prior to study entry.
Contraindication to hepatic artery embolization procedures:
- Severe peripheral vascular disease precluding catheterization.
- Large shunt as determined by the investigator (pretesting with TcMAA not required) at the time of first angiogram.
-Hepatofugal blood flow.
-Main portal vein occlusion (e.g. thrombus or tumor).
Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment.
Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.
Advanced liver disease (> 80% liver replacement).
Other significant medical or surgical condition, or any medication or treatment that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.
Ongoing systemic cancer treatment.
Any contraindication for Doxorubicin administration:
WBC <3000 cells/mm3
Neutrophils <1500 cells/mm3
Deficient cardiac function defined as a LVEF of <50% normal
Allergy to Doxorubicin.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Pereira, MD | Contact | +49 71 31 49-38 01 | philippe.pereira@slk-kliniken.de |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Pereira, MD | SLK Klninikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SLK Klinikum | Recruiting | Heilbronn | 74078 | Germany |
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